Morgane de Coen
Mechelen
Summary
Detail-oriented Secure Data Manager specialising in clinical data management and trial oversight. Expertise in data validation, cleaning, and quality control ensures compliance with study specifications and SOPs. Manages external data transfers and maintains blinding for double-blinded studies, safeguarding data integrity. Coordinates cross-functional stakeholders and effectively resolves issues to meet project timelines.
Overview
5
5
years of professional experience
Work History
Secure Data Manager
SGS
Mechelen, Belgium
12.2024 - Current
- Created and reviewed Data Transfer Agreements.
- Conducted quality control of data transfers to ensure data accuracy.
- Facilitated collaboration through effective communication with internal and external stakeholders.
- Resolved issues related to data transfers promptly, to minimize disruption.
- Maintained blinding for double-blinded clinical studies, preserving study integrity.
- Adhered to project timelines for deliverables, ensuring timely completion.
Clinical Data Manager
SGS
Mechelen, Belgium
08.2022 - 12.2024
- Coordinated data management start-up activities, including protocol review, timeline assessment and essential document preparation.
- Validated external data transfers and coding to ensure compliance with study specifications and SOPs.
- Cleaned and reviewed clinical trial data through electronic validation rules and manual checks.
- Issued and resolved queries.
- Managed SAE reconciliation and protocol deviations.
- Managed external data transfers while collaborating with cross-functional stakeholders to uphold data quality.
- Performed database lock activities by securing sponsor approvals and completing database checklists.
- Ensured timely execution of freeze, unblinding, and lock processes throughout the trial lifecycle.
Internships
KU Leuven
Leuven, Belgium
11.2020 - 06.2022
- Read different research papers for literature studies.
- Conducted laboratory experiments, including PCR, gel electrophoresis, H&E staining, immunostaining, microscopy, cell culture, mouse work, DNA purification.
- Performed data analysis using ImageJ, Excel, and RStudio.
- Authored detailed reports summarizing research findings.
- Presented findings to colleagues for feedback.
Education
Master of Science - Biomedical Sciences
KU Leuven
Leuven2022
Bachelor of Science - Biomedical Sciences
KU Leuven
Leuven2020
Skills
- Clinical data management and trial oversight
- Data validation, cleaning, and quality control
- External data transfer management (DTA review, compliance, and reconciliation)
- Database freeze, unblinding, and lock activities
- SAE reconciliation and protocol deviation management
- Cross-functional stakeholder co-ordination
- Time management
- Problem solving
Timeline
Secure Data Manager
SGS
12.2024 - Current
Clinical Data Manager
SGS
08.2022 - 12.2024
Internships
KU Leuven
11.2020 - 06.2022
Master of Science - Biomedical Sciences
KU Leuven
Bachelor of Science - Biomedical Sciences
KU Leuven